FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

892 results for "Boston Scientific"
505–528 of 892
Search insights Median review: 81d Cleared: 100% Top manufacturer: Boston Scientific Corp Lead specialty: Cardiovascular
Cleared Jun 04, 2003
BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC
K023691 · NFA
Boston Scientific Epi
Cardiovascular · 215d
Cleared May 23, 2003
NAVIGATOR URETERAL ACCESS SHEATH SET
K030956 · FED
Boston Scientific Corp
Gastroenterology & Urology · 57d
Cleared May 21, 2003
PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE
K030617 · DQX
Boston Scientific Scimed, Inc.
Cardiovascular · 84d
Cleared May 14, 2003
MATRIX STRETCH RESISTANT DETACHABLE COIL
K031168 · HCG
Boston Scientific, Target
Neurology · 30d
Cleared Apr 17, 2003
MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG...
K030855 · KNT
Boston Scientific Corp
Gastroenterology & Urology · 30d
Cleared Apr 15, 2003
LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS
K030147 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 90d
Cleared Apr 02, 2003
COBRA BIPOLAR CLAMP, MODEL 15902
K023288 · GEI
Boston Scientific EP Technologies
General & Plastic Surgery · 182d
Cleared Mar 25, 2003
BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT
K030645 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 25d
Cleared Mar 21, 2003
100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM
K030107 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 67d
Cleared Mar 17, 2003
MODIFICATION TO CONTOUR POLARIS URETERAL STENT
K030503 · FAD
Boston Scientific Corp
Gastroenterology & Urology · 26d
Cleared Mar 14, 2003
GDC STRETCH RESISTANT DETACHABLE COIL
K030475 · HCG
Boston Scientific, Target
Neurology · 29d
Cleared Jan 28, 2003
VAXCEL WITH PASV PORT
K030083 · LJT
Boston Scientific Corp
General Hospital · 19d
Cleared Jan 06, 2003
MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
K024048 · FGE
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 28d
Cleared Dec 20, 2002
FLEXIMA BILIARY CATHETER
K023870 · FGE
Boston Scientific/Medi-Tech
Gastroenterology & Urology · 30d
Cleared Nov 26, 2002
RENEGADE STC 18 MICROCATHETER
K023681 · DQO
Boston Scientific Corp
Cardiovascular · 25d
Cleared Nov 21, 2002
ATLANTIS PV IMAGING CATHETER, MODEL 36456
K022860 · ITX
Boston Scientific, Target
Radiology · 85d
Cleared Nov 18, 2002
CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310,...
K023337 · KTI
Boston Scientific Corp
Ear, Nose, Throat · 42d
Cleared Nov 13, 2002
MICROVASIVE PULMONARY GUIDEWIRE
K022059 · MDM
Boston Scientific Corp
General & Plastic Surgery · 141d
Cleared Oct 25, 2002
BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
K021630 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 161d
Cleared Oct 17, 2002
COBRA COOLED CARDIAC SURGICAL PROBE, MODEL 1596X
K023291 · GEI
Boston Scientific Corp
General & Plastic Surgery · 15d
Cleared Oct 16, 2002
TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE,...
K022357 · DQX
Boston Scientific, Target
Cardiovascular · 89d
Cleared Sep 13, 2002
URETERAL ACCESS SHEATH SET (UASS)
K022135 · KOD
Boston Scientific Corp
Gastroenterology & Urology · 74d
Cleared Sep 11, 2002
CONVOY ADVANCED DELIVERY SHEATH
K022067 · DBY
Boston Scientific
Immunology · 78d
Cleared Sep 05, 2002
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521
K022648 · KNT
Boston Scientific Corp
Gastroenterology & Urology · 27d